AAJ Demands FDA Withdraw Rule Allowing Drug Companies to Claim Immunity for Failing to Warn Patients of Potential Drug Hazards

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AAJ Demands FDA Withdraw Rule Allowing Drug Companies to Claim Immunity for Failing to Warn Patients of Potential Drug Hazards

For Immediate Release: January 16, 2008

Contact: Cecelia Prewett
202.965.3500, x369

Washington, DC—The American Association for Justice (AAJ) today demanded the Food and Drug Administration (FDA) withdraw a proposed rule that would allow drug companies to claim immunity for failing to warn patients of potential drug hazards.

The rule directly contradicts congressional intent that the duty to warn people of a drug’s hazards rests with the drug company, who is in the best position to warn about problems associated with the drug.

“With this rule the FDA thumbs its nose at Congress, and leaves patients in the dark about the safety of the prescriptions they are given,” said AAJ President, Kathleen Flynn Peterson. “This rule would make it more difficult for consumers injured by prescription drugs to hold drug companies accountable. We encourage Congress to curb this agency’s abuse of power.”

A new law enacted last fall (the Food and Drug Administration Amendments Act of 2007) required drug companies to update prescription drug labels to warn consumers of drug hazards at the earliest sign of a problem. However, under this FDA rule, drug companies would only have to update its label after they establish a “causal association” between the drug and the hazard, which could take years. This leaves the drug companies too much discretion in determining when to include safety hazards on a drug’s warning label.

“The FDA’s own mission states, they will ‘protect the public health by ensuring that human drugs are safe and effective,’” said Flynn Peterson. “By letting the drug companies decide not to update labels even when there is evidence of potential risks, the FDA is taking a step backward in protecting consumers from harmful drugs. The drug companies couldn’t get this authority added to the legislation, so they’re getting the Bush Administration to ignore Congress and do it for them.”

In addition to this FDA rule, the Bush Administration has a pattern of ignoring clear congressional intent and protecting companies over consumers. A few examples include:

  • Food and Drug Administration: In 2006 the FDA angered both Democrats and Republicans in Congress by issuing a drug labeling rule that preempted state law despite the fact that the agency had long held the opposite view. Senators Kennedy and Dodd, senior Democrats on the committee that oversees the FDA, criticized the agency for adding the language without allowing comments, and described the assertion of preemption as “a drastic reversal of policy with … far-reaching implications.”
  • Federal Railroad Administration: Just four days after Congress passed the Implementing Recommendations of the 9/11 Commission Act of 2007 that preserved railroad derailment victims’ ability to hold railroad companies accountable for their injuries, the Federal Railroad Administration also issued a proposed rule which sought to provide immunity to negligent railroad companies in event of a commuter train derailment.
  • Department of Homeland Security (DHS): DHS claimed preemption of state laws in a 2006 rule regarding chemical facility safety. The rule left state and local communities with the responsibility for any necessary clean-up and emergency response, despite the fact that the Senate Homeland Security and Governmental Affairs Committee expressly rejected such an approach just a year earlier. Senators Lieberman, Collins and Lautenberg, admonished DHS Secretary Michael Chertoff for the failure to recognize, or even discuss, the fact that Congress never intended state laws to be preempted.
  • National Highway and Traffic Safety Administration (NHTSA): In 2005, the NHTSA proposed rules on seatbelts and roof-crush resistance that would preempt state common-law claims. The move sparked criticism from Senators Specter and Leahy. A senior NHTSA official involved in the roof-crush rule later told the Los Angeles Times that the preemption issue had been handled in a way “different from how we normally operated… [The rule] was dropped in from out of the blue.”

AAJ will be submitting comments to the FDA demanding the withdrawal of the rule prior to the close of the comment period and encouraging congressional oversight.

As the world's largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org/newsroom.

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